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510(k) K891351

NEWPORT LATERAL VAGINAL RETRACTOR by Simpson/Basye, Inc. — Product Code KOH

K891351 is an FDA 510(k) premarket notification submitted by Simpson/Basye, Inc. for the device "NEWPORT LATERAL VAGINAL RETRACTOR". The FDA issued a decision of Substantially Equivalent on May 11, 1989. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. Simpson/Basye, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1989
Date Received
March 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, General Obstetric-Gynecologic
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances by Simpson/Basye, Inc.

  • K926179 — SEDLACEK HANDLE (March 25, 1994)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)
  • K891350 — NEWPORT CERVICAL MANIPULATOR (March 29, 1989)
  • K891347 — REID ENDOCERVICAL SPREADER (March 29, 1989)
  • K891349 — CAMPION CERVICAL HOOK (March 29, 1989)
  • K891348 — CAMPION LASER FORCEPS (March 22, 1989)
  • K870276 — HEATED INSTRUMENT BATH (May 7, 1987)
  • K862717 — HAND MIRROR (ENDOSCOPE) (July 30, 1986)
  • K862629 — SURGICAL LASER ACCESSORIES (SLA) CASE (July 17, 1986)
  • K790923 — MI-MARK ENDOCERVICAL SAMPLING SET (June 22, 1979)

Other clearances for product code KOH

  • K000212 — KSEA CHARDONNES MORCELLATION KNIFE (April 21, 2000)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K892693 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (May 11, 1989)
  • K891035 — NEEDLE EXTENSIONS (March 22, 1989)
  • K891049 — ZEPPELIN SCISSORS (March 17, 1989)
  • K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (January 7, 1987)
  • K840308 — CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (March 5, 1984)
  • K823792 — QUARTZ RETRACTOR/PROBE (January 18, 1983)
  • K812204 — UTERINE MANIPULATORS (October 13, 1981)

FDA data resources