510(k) K933085

GOODMAN BANDAGE by Megadyne Medical Products, Inc. — Product Code KGY

K933085 is an FDA 510(k) premarket notification submitted by Megadyne Medical Products, Inc. for the device "GOODMAN BANDAGE". The FDA issued a decision of Substantially Equivalent on December 23, 1993. The device falls under product code KGY (Bag, Intestine), a Class I device regulated under 21 CFR 878.4100. Megadyne Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 23, 1993
Date Received: June 23, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bag, Intestine
Device Class: Class I
Regulation Number: 878.4100
Review Panel: SU
Submission Type

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)

510(k) K933085

Clearance Details

Device Classification

Other clearances by Megadyne Medical Products, Inc.

Other clearances for product code KGY

FDA data resources