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510(k) K790102

MODEL 556-01 CRYOEXTRACTOR by Intermedics, Inc. — Product Code HPS

K790102 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "MODEL 556-01 CRYOEXTRACTOR". The FDA issued a decision of Substantially Equivalent on February 12, 1979. The device falls under product code HPS (Unit, Cryophthalmic), a Class II device regulated under 21 CFR 886.4170. Intermedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1979
Date Received
January 16, 1979
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 Intermedics, Inc.

  • K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD (December 16, 1996)
  • K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL (November 4, 1996)
  • K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) (August 21, 1996)
  • K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD (June 19, 1996)
  • K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (June 18, 1996)
  • K954719 — INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (February 27, 1996)
  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K922042 — CARDIFIX ENDOCARDIAL PACING LEAD (April 29, 1993)
  • K922972 — MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD (January 22, 1993)
  • K920530 — INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG (March 17, 1992)

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)
  • 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)

FDA data resources