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510(k) K920763

LACERATTION TRAY by Sterile Concepts, Inc. — Product Code KDD

K920763 is an FDA 510(k) premarket notification submitted by Sterile Concepts, Inc. for the device "LACERATTION TRAY". The FDA issued a decision of Substantially Equivalent (kit) on September 28, 1992. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Sterile Concepts, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
September 28, 1992
Date Received
February 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Sterile Concepts, Inc.

  • K951231 — ORTHOPEDIC PACKS (December 1, 1995)
  • K951081 — OB/GYN PACKS (November 13, 1995)
  • K952539 — RADIOLOGY PACKS (July 14, 1995)
  • K951478 — GENERAL AND PLASTIC SURGERY PACKS (June 13, 1995)
  • K944139 — DENTAL HYGIENE TRAY (December 15, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K943090 — SUTURE REMOVAL TRAYS (August 22, 1994)
  • K940864 — DENTIST WITH ASSISTANT PACK (August 2, 1994)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources