Cleared Traditional

K860892 - CLINAGEL (ABSORBENT GEL)

K860892 · Schering Chemicals, C/O Ellis Pharmaceuticals · General & Plastic Surgery device
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Jul 1986
Decision
135d
Days
-
Risk

K860892 is an FDA 510(k) clearance for the CLINAGEL (ABSORBENT GEL). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Schering Chemicals, C/O Ellis Pharmaceuticals (Princeton, US). The FDA issued a Cleared decision on July 23, 1986 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Schering Chemicals, C/O Ellis Pharmaceuticals devices

FDA 510(k) Submission Details - K860892

510(k) Number K860892 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 10, 1986
Decision Date July 23, 1986
Days to Decision 135 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
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 601
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K860892.
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K862803 · Chesebrough-Pond'S U.S.A. Co. · Nov 1986
HYDROCOLLOID DRESSINGS - STERILE
K863390 · Convatec, A Division of E.R. Squibb & Sons · Sep 1986
HOLLISTER WOUND CARE BARRIER
K862572 · Hollister, Inc. · Aug 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · Johnson & Johnson Professionals, Inc. · Jul 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · Johnson & Johnson Professionals, Inc. · Jul 1986
BARD ABSORPTION DRESSING
K861024 · C.R. Bard, Inc. · Apr 1986