510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031527Substantially Equivalent

Modification to Cavermap Surgical Aid

Blue Torch Medical Technologies, Newton MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031527 is the FDA 510(k) clearance record for MODIFICATION TO CAVERMAP SURGICAL AID, a class I device, cleared for Blue Torch Medical Technologies on under FDA product code FGM (Probe And Director, Gastro-Urology). FDA records list 2 510(k) clearances for Blue Torch Medical Technologies, from to . As of , FDA records show no recalls naming K031527.

Clearance record

Decision date
Received
(21 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
Blue Torch Medical Technologies 180 Wells Ave., Newton MA
510(k) summary
Summary PDF
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