510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860892Substantially Equivalent for Some Indications

Clinagel (Absorbent Gel)

Schering Chemicals, C/O Ellis Pharmaceuticals, Princeton NJ / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K860892 is the FDA 510(k) clearance record for CLINAGEL (ABSORBENT GEL), cleared for Schering Chemicals, C/O Ellis Pharmaceuticals on under FDA product code FRO (Dressing, Wound, Drug). FDA records list one 510(k) clearance for Schering Chemicals, C/O Ellis Pharmaceuticals. As of , FDA records show no recalls naming K860892.

Clearance record

Decision date
Received
(135 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Schering Chemicals, C/O Ellis Pharmaceuticals 913 State Rd., Princeton NJ
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260