510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993436Substantially Equivalent

Cavermap Surgical Aid

Uromed Corp., Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993436 is the FDA 510(k) clearance record for CAVERMAP SURGICAL AID, a class I device, cleared for Uromed Corp. on under FDA product code FGM (Probe And Director, Gastro-Urology). FDA records list 10 510(k) clearances for Uromed Corp., from to . As of , FDA records show one recall naming K993436.

Clearance record

Decision date
Received
(122 days to decision)
Product code
FGM Probe And Director, Gastro-Urology
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Uromed Corp. 1400 Providence Hwy., Norwood MA
510(k) summary
Summary
Third party review
No

Clearances, product code FGM

Trailing 12 months

FDA records hold no clearances under product code FGM in the trailing twelve months.

FDA records show no clearances under product code FGM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260