NEWPORT LATERAL VAGINAL RETRACTOR— 510(k) K891351

Name: FDA 510(k) clearance K891351
Creator: U.S. Food and Drug Administration
Published: 1989-05-11

Substantially Equivalent

Simpson/Basye, Inc.

FDA 510(k) clearance K891351 for NEWPORT LATERAL VAGINAL RETRACTOR, Substantially Equivalent on 1989-05-11. Applicant: Simpson/Basye, Inc.. Device class: 1.

Clearance details

Applicant: Simpson/Basye, Inc.
Product code: Code KOH
Device class: Class 1
Regulation: 21 CFR 884.4520
Advisory panel: Obstetrics/Gynecology
Date received: 1989-03-10
Decision date: 1989-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOH

view all

K000212 — KSEA CHARDONNES MORCELLATION KNIFE2000-04-21
K921730 — C-SECTION PACK1994-06-15
K921732 — MINOR LAP SET1994-06-15
K892693 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT1989-05-11
K891035 — NEEDLE EXTENSIONS1989-03-22

More clearances from Simpson/Basye, Inc.

view all

K926179 — SEDLACEK HANDLE1994-03-25
K891352 — MARLOW ANAL SPECULUM1989-06-23
K891347 — REID ENDOCERVICAL SPREADER1989-03-29
K891349 — CAMPION CERVICAL HOOK1989-03-29
K891350 — NEWPORT CERVICAL MANIPULATOR1989-03-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.