SURGICADE GAUZE SPONGE
Device Facts
| Record ID | K962972 |
|---|---|
| Device Name | SURGICADE GAUZE SPONGE |
| Applicant | Accunex Canada,Inc. |
| Product Code | EFQ · SU |
| Decision Date | Oct 11, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Therapeutic |
Intended Use
Control bleeding, absorb body fluids, and protect wounds from contamination.
Device Story
Surgicade™ Non-Sterile Gauze Sponges; composed of USP Type VII gauze; used for bleeding control, fluid absorption, and wound protection; available in 8, 12, and 16 ply thicknesses in various dimensions; intended for clinical or general wound care settings; applied by healthcare providers or patients; provides physical barrier and absorbent surface for wound management.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Material: USP Type VII gauze. Construction: 8, 12, and 16 ply. Dimensions: 2"x2", 3"x3", 4"x4", 4"x8". Non-sterile.
Indications for Use
Indicated for patients requiring wound management to control bleeding, absorb body fluids, and protect wounds from external contamination.
Predicate Devices
- Non-Sterile Gauze Sponges (Team Mfg., Inc.) (K922055)
- Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products) (K942070)
Related Devices
- K961773 — PROTEC STERILE GAUZE SPONGE · Derivadas Degasa S.A. DE C.V. · Jul 29, 1996
- K983450 — STARRYSHINE GAUZE SPONGE · T.C. Dental Products, Inc. · Nov 12, 1998
- K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE · Broadline Medical Industries · Apr 23, 1999
- K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE · Furlong Industries · Aug 12, 1999
- K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES · Primeline Medical Products, Inc. · Jun 22, 1997
Submission Summary (Full Text)
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K962972
510 (k) SUMMARY
Oct. 11, 1996
## I. ADMINISTRATIVE
**Submitter:** Accunex Canada, Inc.
202-2117 West 5th Avenue
Vancouver, B.C.
Canada V6J 1P8
604-736-4219
**Contact Person:** Mr. Xianping Huang
**Date of Preparation:** July 30, 1996
## II. DEVICE NAME
**Proprietary Name:** Surgicade™ Non-Sterile Gauze Sponges
**Common Name:** Wound Dressing
**Classification Name:** Gauze Sponge
## III. PREDICATE DEVICES
Non-Sterile Gauze Sponges (Team Mfg., Inc.); K922055.
Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products); K942070
## IV. DEVICE DESCRIPTION
Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type VII gauze, available in thicknesses of 8 ply (2" × 2", 3" × 3", 4" × 4", 4" × 8"), 12 ply (2" × 2", 3" × 3", 4" × 4", 4" × 8"), and 16 ply (4" × 4").
## V. INTENDED USE
Control bleeding, absorb body fluids, and protect wounds from contamination.
## VI. COMPARISON TO PREDICATE DEVICES
Surgicade™ Non-Sterile Gauze Sponges are similar or identical in composition, function and intended use to legally marketed gauze sponges, such as Non-Sterile Gauze Sponges (Team Mfg., Inc.) and Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products). All such devices are composed of absorbent gauze in various thicknesses and sizes, and have the same intended use.
Accordingly, Accunex Canada Inc. has concluded that the Surgicade™ Non-Sterile Gauze Sponges are safe and effective for their intended use and perform at least as well as legally marketed predicate devices, such as the Team Non-Sterile Gauze Sponges and Lorrex Non-Sterile Cover Sponges.
Premarket Notification: Surgicade Non-Sterile Gauze Sponge
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