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510(k) K860357

HGM, INC. LASERCATH (STERILE) by Hgm, Inc. — Product Code LNK

K860357 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "HGM, INC. LASERCATH (STERILE)". The FDA issued a decision of Substantially Equivalent on April 7, 1986. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Hgm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1986
Date Received
January 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type

Other clearances by Hgm, Inc.

  • K950120 — SMART PLUG (August 11, 1995)
  • K931072 — HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE (November 10, 1994)
  • K931784 — HGM ILLUMINATING IMAGING ENDOCULAR PROBE (March 1, 1994)
  • K933333 — HGM SCANMAN PLUS (September 23, 1993)
  • K931499 — Q-11 OPHTHALMIC LASER (August 19, 1993)
  • K925663 — HGM ASPIRATING ENDOOCULAR(TM) PROBE (August 17, 1993)
  • K930543 — E-25 KRYPTON ION LASER (SURGICA K5) (June 22, 1993)
  • K880908 — MODEL PC ARGON LASER (May 3, 1988)
  • K873773 — ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER (October 13, 1987)
  • K872630 — ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. (August 25, 1987)

Other clearances for product code LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)

FDA data resources