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510(k) K950780

AMSINO CERVICAL SCRAPER by Amsino Intl., Inc. — Product Code HHT

K950780 is an FDA 510(k) premarket notification submitted by Amsino Intl., Inc. for the device "AMSINO CERVICAL SCRAPER". The FDA issued a decision of Substantially Equivalent on July 25, 1995. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Amsino Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1995
Date Received
February 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Cervical, Cytological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Amsino Intl., Inc.

  • K070873 — AMSURE BLADDER IRRIGATION SET (December 19, 2007)
  • K992719 — AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE (January 12, 2000)
  • K974042 — AMSURE CLEANSING ENEMA SET (December 19, 1997)
  • K973107 — AMSINO I.V. ADMINISTRATION SET (October 2, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K951528 — AMSINO DISPOSABLE VIGINAL SPECULUM (May 11, 1995)

Other clearances for product code HHT

  • K182049 — exCellerator Cervical Collection Device (April 25, 2019)
  • K153128 — Kolplast Cervical Sample Collection Kit (January 13, 2017)
  • K141057 — DISPOSABLE CERVICAL BRUSH (May 14, 2015)
  • K111681 — HISTOBRUSH (January 19, 2012)
  • K083012 — PAPCONE (April 9, 2009)
  • K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY (December 5, 2008)
  • K072381 — SOFTPAP CERVICAL CELL COLLECTOR (January 30, 2008)
  • K062433 — DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM (March 16, 2007)
  • K043369 — CERVEX-BRUSH COMBI (February 2, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)

FDA data resources