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

Set, Anesthesia, Paracervical

21 CFR 884.5100 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HEE is the FDA product code for Set, Anesthesia, Paracervical, a class II device type, regulated under 21 CFR 884.5100. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HEE
Device name
Set, Anesthesia, Paracervical
Regulation
21 CFR 884.5100
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
1

Clearances, product code HEE

By decision year
9 clearances under product code HEE with a decision year between 1991 and 2005, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HEE by decision year
YearClearances
19912
19961
19971
19981
19991
20001
20021
20051

Applicants with the most clearances

Product code HEE
Applicants holding the most 510(k) clearances under product code HEE
ApplicantClearances
CooperSurgical, Inc.3
A & A Medical, Inc.1
Avid Medical, Inc. a Medical Action Ind. Company 3051
Ellman Intl., Inc.1
Gynex Corp.1
Ri Mos. S.r.l.1
Rocket Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code