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

Loupe, Diagnostic/Surgical

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

FSP is the FDA product code for Loupe, Diagnostic/Surgical, 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 3 recalls.

Classification record

Product code
FSP
Device name
Loupe, Diagnostic/Surgical
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
3

Clearances, product code FSP

By decision year
4 clearances under product code FSP with a decision year between 1986 and 1989, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FSP by decision year
YearClearances
19862
19892

Applicants with the most clearances

Product code FSP
Applicants holding the most 510(k) clearances under product code FSP
ApplicantClearances
Luxtec Corp.2
Keeler Instruments, Inc.1
Zinnanti Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 60 companies shown, in name order