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510(k) K902242

ENDOCERVICAL ASPIRATOR by Innovative Medical Products, Inc. — Product Code HFC

K902242 is an FDA 510(k) premarket notification submitted by Innovative Medical Products, Inc. for the device "ENDOCERVICAL ASPIRATOR". The FDA issued a decision of Substantially Equivalent on October 9, 1990. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050. Innovative Medical Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1990
Date Received
May 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspirator, Endocervical
Device Class
Class II
Regulation Number
884.1050
Review Panel
OB
Submission Type

Other clearances by Innovative Medical Products, Inc.

  • K914538 — UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER (July 14, 1992)

Other clearances for product code HFC

  • K974032 — ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY (December 22, 1997)
  • K960263 — CERVICAL MUCOUS ASPIRATION CATHETER (August 29, 1996)
  • K954903 — PEDI VAGINAL ASPIRATOR (April 29, 1996)
  • K954102 — SELECTMUCUS (November 21, 1995)
  • K902032 — O. B. PACK IV (September 28, 1990)
  • K902954 — OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) (August 23, 1990)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K821134 — DC PACK TM (June 22, 1982)
  • K812175 — ENDOCERVICAL ASPIRATOR (September 21, 1981)
  • K801238 — ACCU-PAP T ZONE SAMPLER (August 12, 1980)

FDA data resources