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510(k) K800834

SER-TEX by V.S.S.I., Inc. — Product Code KOH

K800834 is an FDA 510(k) premarket notification submitted by V.S.S.I., Inc. for the device "SER-TEX". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1980
Date Received
April 14, 1980
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 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)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • 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)

FDA data resources