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510(k) K902032

O. B. PACK IV by Customed, Inc. — Product Code HFC

K902032 is an FDA 510(k) premarket notification submitted by Customed, Inc. for the device "O. B. PACK IV". The FDA issued a decision of Substantially Equivalent on September 28, 1990. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050. Customed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1990
Date Received
May 4, 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 Customed, Inc.

  • K260116 — CustoMED Viewer (June 3, 2026)
  • K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 (January 5, 1998)
  • K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (December 4, 1997)
  • K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277 (November 25, 1996)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K962596 — CUSTOMED BLOOD EXTRACTION KIT (September 27, 1996)
  • K961442 — UNIVERSAL DRAINAGE TRAY (May 9, 1996)
  • K953678 — STERIMED STERIZATION WRAPPER (NON-STERILE) (October 2, 1995)
  • K950295 — WOUND CLOSURE/LACERATION TRAY (April 18, 1995)
  • K942177 — FOLEY CATHETERIZATION TRAY (September 8, 1994)

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)
  • 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