510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920104Substantially Equivalent

Identi Loops Degania Silicone

Puritas Health Care, Inc., Brookfield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920104 is the FDA 510(k) clearance record for IDENTI LOOPS DEGANIA SILICONE, a class II device, cleared for Puritas Health Care, Inc. on under FDA product code DSS (Clip, Vascular). FDA records list 24 510(k) clearances for Puritas Health Care, Inc., from to . As of , FDA records show no recalls naming K920104.

Clearance record

Decision date
Received
(102 days to decision)
Product code
DSS Clip, Vascular
Regulation
21 CFR 870.3250
Device class
Class II
Review panel
Cardiovascular
Applicant
Puritas Health Care, Inc. 76 Stony Hill Village, Brookfield CT
510(k) summary
Summary
Third party review
No

Clearances, product code DSS

Trailing 12 months

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

FDA records show no clearances under product code DSS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DSS, 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