Cleared Traditional

K951417 - CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS

K951417 · Carrington Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
43d
Days
-
Risk

K951417 is an FDA 510(k) clearance for the CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS. 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 May 10, 1995 after a review of 43 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.

FDA 510(k) Submission Details - K951417

510(k) Number K951417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1995
Decision Date May 10, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
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 138
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K951417.
MPM HYDROGEL DRESSING
K952276 · Mpm Medical., Inc. · Jun 1995
MPM HYDROGEL DRESSING
K950934 · Richard Hamer Assoc., Inc. · May 1995
HYDROGEL DRESSING
K945217 · O.R. Resources, Inc. · May 1995
PANOPLEX HYDROGEL WOUND DRESSING
K945005 · Sage Pharmaceuticals, Inc. · Mar 1995
BIAFINE
K943910 · Laboratoire Medix · Feb 1995
DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
K946030 · Wilshire Medical Products · Feb 1995
K951417 · CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS
Download PDF FDA Summary Carrington Laboratori…