Cleared Traditional

K961758 - CARASYN HYDROGEL WOUND PRODUCTS

K961758 · Carrington Laboratories, Inc. · General & Plastic Surgery device
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Jul 1996
Decision
69d
Days
-
Risk

K961758 is an FDA 510(k) clearance for the CARASYN HYDROGEL WOUND PRODUCTS. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Carrington Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on July 11, 1996 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carrington Laboratories, Inc. devices

FDA 510(k) Submission Details - K961758

510(k) Number K961758 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 03, 1996
Decision Date July 11, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 47
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K961758.
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · Sage Pharmaceuticals, Inc. · Jan 1997
BRENNEN MEDICAL GLUCAN II WOUND DRESSING
K964241 · Brennen Medical, Inc. · Dec 1996
DERMAPLEX HYDROGEL WOUND DRESSING
K962513 · Maxxim Medical · Sep 1996
TECNOL HYDROGEL WOUND DRESSING
K955575 · Tecnol Medical Products, Inc. · Jan 1996
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING
K954664 · Derma Sciences, Inc. · Nov 1995