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510(k) K954102

SELECTMUCUS by Select Medical Systems, Inc. — Product Code HFC

K954102 is an FDA 510(k) premarket notification submitted by Select Medical Systems, Inc. for the device "SELECTMUCUS". The FDA issued a decision of Substantially Equivalent on November 21, 1995. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050. Select Medical Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1995
Date Received
August 31, 1995
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 Select Medical Systems, Inc.

  • K012935 — THECURVE, ITEM 507 (October 11, 2001)
  • K974819 — SELECTCELLS(TM) MINI (March 23, 1998)
  • K954099 — SELECT IUI (November 22, 1995)
  • K954097 — SELECTCELLS STANDARD (November 21, 1995)
  • K942922 — SELECTA 20/60 CHEMISTRY ANALYZER (July 19, 1995)

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)
  • K902242 — ENDOCERVICAL ASPIRATOR (October 9, 1990)
  • 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