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510(k) K891347

REID ENDOCERVICAL SPREADER by Simpson/Basye, Inc. — Product Code HDC

K891347 is an FDA 510(k) premarket notification submitted by Simpson/Basye, Inc. for the device "REID ENDOCERVICAL SPREADER". The FDA issued a decision of Substantially Equivalent on March 29, 1989. The device falls under product code HDC (Tenaculum, Uterine), a Class II device regulated under 21 CFR 884.4530. Simpson/Basye, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1989
Date Received
March 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tenaculum, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Simpson/Basye, Inc.

  • K926179 — SEDLACEK HANDLE (March 25, 1994)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891350 — NEWPORT CERVICAL MANIPULATOR (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 HDC

  • K223866 — Carevix™ Suction Cervical Stabilizer (January 25, 2023)
  • K203820 — ASPIVIX v1.1 Cervical Suction Tenaculum (August 17, 2021)
  • K142204 — Bioceptive Suction Cervical Retractor (December 19, 2014)
  • K082349 — JARIT HULKA UTERINE TENACULUM FORCEPS (November 21, 2008)
  • K073182 — GYN DISPOSABLES TENACULUM 356T (November 28, 2007)
  • K062563 — FEMTEN CERVICAL TENACULUM (May 18, 2007)
  • K060573 — BURBANK TENACULUM (April 21, 2006)
  • K032585 — TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM (January 9, 2004)
  • K030078 — BURBANK TENACULUM, MODEL 09-0011-01 (January 24, 2003)
  • K001818 — UTERINE TENACLUM HOOK (August 30, 2000)

FDA data resources