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510(k) K915064

DISPOSABLE CAUTERY ABRASIVE PAD by American Medical Mfg., Inc. — Product Code KDC

K915064 is an FDA 510(k) premarket notification submitted by American Medical Mfg., Inc. for the device "DISPOSABLE CAUTERY ABRASIVE PAD". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. American Medical Mfg., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
November 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by American Medical Mfg., Inc.

  • K982029 — SHARPS COLLECTION CONTAINER - SAF-T-SHELL (April 6, 1999)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K915066 — DISPOSABLE SKIN MARKER (May 14, 1992)
  • K915065 — I.V.IRRIGATION POLE (February 11, 1992)
  • K915068 — PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER (February 6, 1992)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)

FDA data resources