510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K060801Substantially Equivalent

Dekna-Lok Model Bp1000v2l

Teleflex Medical, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060801 is the FDA 510(k) clearance record for DEKNA-LOK MODEL BP1000V2L, a class II device, cleared for Teleflex Medical on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 80 510(k) clearances for Teleflex Medical, from to . As of , FDA records show no recalls naming K060801.

Clearance record

Decision date
Received
(54 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Teleflex Medical 2917 Weck Dr., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
6 clearances under product code GAM in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260