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510(k) K870195

UNITED SURGICAL CORP. CRYOPTIC PLUS by United Surgical Corp. — Product Code HPS

K870195 is an FDA 510(k) premarket notification submitted by United Surgical Corp. for the device "UNITED SURGICAL CORP. CRYOPTIC PLUS". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code HPS (Unit, Cryophthalmic), a Class II device regulated under 21 CFR 886.4170. United Surgical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1987
Date Received
January 20, 1987
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 United Surgical Corp.

  • K902150 — PIEZO HANDPIECE (July 5, 1990)
  • K870671 — PHACOTRON DAY PAK (April 6, 1987)
  • K870806 — NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 (March 26, 1987)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)
  • K860014 — SYSTEMS PLUS (March 5, 1986)
  • K830741 — PARAMETRIC STERILITY RELEASE OF AUTO (August 11, 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)
  • K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES (October 11, 1990)
  • K874555 — KEELER ACU 22XT OPHTHALMIC CRYO UNIT (January 29, 1988)
  • K873388 — KEELER CTU CRYO SYSTEM (November 13, 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