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510(k) K903303

SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES by Spembly Medical , Ltd. — Product Code HPS

K903303 is an FDA 510(k) premarket notification submitted by Spembly Medical , Ltd. for the device "SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES". The FDA issued a decision of Substantially Equivalent on October 11, 1990. The device falls under product code HPS (Unit, Cryophthalmic), a Class II device regulated under 21 CFR 886.4170. Spembly Medical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1990
Date Received
July 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

Other clearances by Spembly Medical , Ltd.

  • K925129 — SELECTOR (April 23, 1993)
  • K901974 — SELECTOR ULTRASONIC SURGICAL ASPIRATOR (September 5, 1990)
  • K882568 — 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY (September 27, 1988)
  • K882962 — SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) (August 8, 1988)
  • K882963 — SPEMBLY MEDICAL 142 CRYO UNIT (August 8, 1988)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 1988)
  • K840497 — OBSTETRIC PULSAR TWO CHANNEL TENS (April 16, 1984)
  • K832385 — CRYOPROBES MC-1400-CRYOSURG-CONSOLE (September 12, 1983)
  • K831963 — CRYOMEDICS NEUROSTAT (August 12, 1983)
  • K832140 — CRYOMEDICS 5000 CRYOPROBES (August 12, 1983)

Other clearances for product code HPS

  • K202038 — CryoTreQ (December 30, 2020)
  • K940373 — OPHTHALMIC CRYO UNIT (July 18, 1994)
  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K874555 — KEELER ACU 22XT OPHTHALMIC CRYO UNIT (January 29, 1988)
  • K873388 — KEELER CTU CRYO SYSTEM (November 13, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • K833747 — GALLIE CRYONUCLEATOR (May 9, 1984)
  • K801418 — KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT (July 21, 1980)
  • K781338 — BEAVER CATARACT CYROXTRACTOR (February 12, 1979)
  • K790102 — MODEL 556-01 CRYOEXTRACTOR (February 12, 1979)

FDA data resources