510(k) K791888

CATHETER CARE KIT REORDER 7940&7941 by Ascep, Inc. — Product Code EFQ

K791888 is an FDA 510(k) premarket notification submitted by Ascep, Inc. for the device "CATHETER CARE KIT REORDER 7940&7941". The FDA issued a decision of Substantially Equivalent on Oct 17, 1979. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Ascep, Inc. has 8 other 510(k) clearances on record.

Clearance details

Decision: SESE (Substantially Equivalent)
Decision Date: Oct 17, 1979
Date Received: Sep 11, 1979
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device classification

Device Name: Gauze/Sponge, Internal
Device Class: Class U
Review Panel: SU
Submission Type: 510(k)

Other clearances by Ascep, Inc.

K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (Apr 12, 1983)
K822893 — G.E.V. DISPOSABLE SCALPELS (Oct 22, 1982)
K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (Jan 26, 1981)
K802726 — INSTRUMENTS NONSTERILE & STERILE (Nov 19, 1980)
K791886 — I.V. CARE KIT (Oct 26, 1979)
K791885 — I.V. START SET (Oct 22, 1979)
K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (Oct 17, 1979)
K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (Oct 17, 1979)

Other clearances for product code EFQ

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

510(k) K791888

Clearance details

Device classification

Other clearances by Ascep, Inc.

Other clearances for product code EFQ

FDA data resources