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510(k) K910361

SUTURE REMOVAL KIT by Megadyne Medical Products, Inc. — Product Code MCZ

K910361 is an FDA 510(k) premarket notification submitted by Megadyne Medical Products, Inc. for the device "SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent on March 27, 1991. The device falls under product code MCZ (Suture Removal Kit), a Class I device regulated under 21 CFR 878.4800. Megadyne Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1991
Date Received
January 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture Removal Kit
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Megadyne Medical Products, Inc.

  • K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Pa (July 12, 2024)
  • K213696 — ETHICON Megadyne Electrosurgical Generator (January 21, 2022)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (March 24, 2020)
  • K191328 — Megadyne Foot Switch (July 26, 2019)
  • K141587 — E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA F (February 18, 2015)
  • K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE (January 24, 2014)
  • K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (December 16, 2008)
  • K081791 — E-Z CLEAN ELECTROSURGICAL ELECTRODE (October 21, 2008)
  • K072559 — SUCTION COAGULATOR (October 5, 2007)

Other clearances for product code MCZ

  • K050656 — AMSINO SUTURE REMOVAL KIT (May 2, 2005)
  • K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT (February 14, 1997)
  • K963714 — GRAND MEDICAL SUTURE REMOVAL KIT (November 27, 1996)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)
  • K941465 — SUTURE REMOVAL KIT (April 22, 1994)
  • K931597 — CARAPACE INCISION AND DRAINAGE TRAYS (November 5, 1993)
  • K925015 — STERILE SUTURE REMOVAL KIT (June 7, 1993)
  • K924835 — VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 (March 23, 1993)
  • K924834 — PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) (March 23, 1993)
  • K922339 — SUTURE REMOVAL KIT (December 11, 1992)

FDA data resources