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

Applier, Hemostatic Clip

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

HBT is the FDA product code for Applier, Hemostatic Clip, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
HBT
Device name
Applier, Hemostatic Clip
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
14

Clearances, product code HBT

By decision year
4 clearances under product code HBT with a decision year between 1980 and 1993, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HBT by decision year
YearClearances
19801
19861
19901
19931

Applicants with the most clearances

Product code HBT
Applicants holding the most 510(k) clearances under product code HBT
ApplicantClearances
Downs Surgical, Ltd.1
Edward Weck, Inc.1
Richard-Allan Medical1
Richard-Allan Medical Ind., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order