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510(k) K811951

DRESSING CHANGE TRAYS & STERILE SPONGES by O.R. Specialties, Inc. — Product Code EFQ

K811951 is an FDA 510(k) premarket notification submitted by O.R. Specialties, Inc. for the device "DRESSING CHANGE TRAYS & STERILE SPONGES". The FDA issued a decision of Substantially Equivalent on October 16, 1981. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. O.R. Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1981
Date Received
July 7, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by O.R. Specialties, Inc.

  • K942607 — LAPAROSCOPIC SCISSORS (DISPOSABLE) (July 6, 1994)
  • K923630 — PHACO NEEDLES 1000-R & 1000-O NEEDLES (April 6, 1994)
  • K925671 — DISPOSABLE SCLERAL PLUGS (August 2, 1993)
  • K923887 — JACK'S VENT TUBES (February 19, 1993)
  • K923774 — DISPOSABLE ENDOILLUMINATOR (October 19, 1992)
  • K922355 — POLLY'S VITREOUS SCISSORS J-225-S (August 18, 1992)
  • K922180 — LEWICKY O.R.S. TUBING (July 2, 1992)
  • K914038 — POLLY'S CUTTER J-225 (December 9, 1991)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890195 — JAMES SURGICAL SYSTEM J1000 (August 3, 1989)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources