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510(k) K812132

STERILE SUTURE REMOVAL KIT by E.M. Adams — Product Code MCZ

K812132 is an FDA 510(k) premarket notification submitted by E.M. Adams for the device "STERILE SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent on December 1, 1981. The device falls under product code MCZ (Suture Removal Kit), a Class I device regulated under 21 CFR 878.4800. E.M. Adams has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1981
Date Received
July 28, 1981
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 E.M. Adams

  • K905173 — SPLASH GUARD (April 25, 1991)
  • K910468 — STERILE DISPOSABLE DRAPE(S) (March 21, 1991)
  • K873978 — DISPOSABLE BIPOLAR FORCEPS (November 23, 1987)
  • K850063 — INSTRUMENT POCKET (February 21, 1985)
  • K843724 — I.V. START KIT & OBSTETRICAL KIT (January 10, 1985)
  • K843783 — WET PACK (December 19, 1984)
  • K843782 — DRY TRAY (December 13, 1984)
  • K843723 — STERILE INSTRUMENT TRAYS-VARIOUS (October 23, 1984)
  • K843115 — STERILE SOLUTION BOWL (September 7, 1984)
  • K843116 — DISPOSABLE SKIN MARKING PEN (August 17, 1984)

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