510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971100Substantially Equivalent

Atrion Medical Autogenous Tissue Collector

Atrion Medical Products, Inc., Arab AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971100 is the FDA 510(k) clearance record for ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR, a class I device, cleared for Atrion Medical Products, Inc. on under FDA product code EIA (Unit, Operative Dental). FDA records list 9 510(k) clearances for Atrion Medical Products, Inc., from to . As of , FDA records show no recalls naming K971100.

Clearance record

Decision date
Received
(58 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Atrion Medical Products, Inc. 1426 Curt Francis Rd., Arab AL
510(k) summary
Summary
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260