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510(k) K895403

ASPIRETTE ENDOCERVICAL ASPIRATOR by Unimar, Inc. — Product Code HFC

K895403 is an FDA 510(k) premarket notification submitted by Unimar, Inc. for the device "ASPIRETTE ENDOCERVICAL ASPIRATOR". The FDA issued a decision of Substantially Equivalent on November 29, 1989. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050. Unimar, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1989
Date Received
September 7, 1989
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 Unimar, Inc.

  • K932432 — KRONNER REINFORCING STYLETTE (April 12, 1994)
  • K920803 — HSG TRAY (October 19, 1992)
  • K910317 — UNI-SEM(TM) (May 1, 1991)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K895659 — HUI MINI-FLEX (December 19, 1989)
  • K894264 — KDF-2.3 (August 15, 1989)
  • K890848 — CERVEX-BRUSH (May 11, 1989)
  • K854415 — ENDOMETRIAL PIPELLE (March 13, 1986)
  • K810291 — STERILE/DISPOSABLE HSG TRAY (March 18, 1981)

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)
  • K902242 — ENDOCERVICAL ASPIRATOR (October 9, 1990)
  • K902032 — O. B. PACK IV (September 28, 1990)
  • K902954 — OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) (August 23, 1990)
  • 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