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510(k) K894891

IRRIGATOR STAND by Commercial Products & Engineering Co. — Product Code HDC

K894891 is an FDA 510(k) premarket notification submitted by Commercial Products & Engineering Co. for the device "IRRIGATOR STAND". The FDA issued a decision of Substantially Equivalent on August 23, 1989. The device falls under product code HDC (Tenaculum, Uterine), a Class II device regulated under 21 CFR 884.4530. Commercial Products & Engineering Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1989
Date Received
August 1, 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 Commercial Products & Engineering Co.

  • K884542 — SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED (November 21, 1988)
  • K883463 — HOSPITAL BED CLOTHING CRADLE (September 19, 1988)
  • K882333 — FLOOR LIGHT (June 23, 1988)
  • K873545 — PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT (November 20, 1987)

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