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510(k) K960239

CPR D & C TRAY by Custom Pack Reliability — Product Code HHK

K960239 is an FDA 510(k) premarket notification submitted by Custom Pack Reliability for the device "CPR D & C TRAY". The FDA issued a decision of Substantially Equivalent on May 23, 1996. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Custom Pack Reliability has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
Review Panel
OB
Submission Type

Other clearances by Custom Pack Reliability

  • K960205 — CPR TRACHEOTOMY CARE TRAY (August 27, 1996)
  • K960243 — CPR C-SECTION DELIVERY PACK (May 23, 1996)
  • K960216 — CPR SUCTION CATHETER KIT (April 15, 1996)
  • K960211 — CPR TOTAL KNEE PACK (April 12, 1996)
  • K960206 — CPR DRESSING CHANGE TRAY (April 12, 1996)
  • K960213 — CPR TOTAL HIP PACK (April 12, 1996)
  • K960210 — CPR ORTHO HAND PACK (April 12, 1996)
  • K960209 — CPR HEART PACK (April 4, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)
  • K960215 — CPR URETHRAL CATHETER TRAY (April 1, 1996)

Other clearances for product code HHK

  • K251882 — Uterine Aspiration Set (October 16, 2025)
  • K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (September 25, 2024)
  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (March 25, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)

FDA data resources