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510(k) K852415

TITANIUM PROBES by L.A.S.E.R., Inc. — Product Code GAD

K852415 is an FDA 510(k) premarket notification submitted by L.A.S.E.R., Inc. for the device "TITANIUM PROBES". The FDA issued a decision of Substantially Equivalent on Aug 2, 1985. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. L.A.S.E.R., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 2, 1985
Date Received
Jun 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by L.A.S.E.R., Inc.

  • K983965 — CO2 LASER COUPLER (Dec 22, 1998)
  • K950021 — REUSABLE TROCAR WITH SAFETY SLEEVE (Mar 31, 1995)
  • K940454 — GRASPING FORCEPS, PUNCHES, SCISSORS (Mar 25, 1994)
  • K931561 — TROCAR SLEEVE (Feb 7, 1994)
  • K933421 — ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES (Nov 2, 1993)
  • K924844 — BULK TISSUE REMOVAL SYSTEM (Oct 8, 1993)
  • K932045 — DISPOSABLE INSUFFLATION TUBING (Sep 23, 1993)
  • K931092 — ENDOSCOPIC RETRACTOR (Apr 30, 1993)
  • K914197 — ALLOY SCALPEL HANDPIECES (Apr 10, 1992)
  • K904638 — TROCAR DISPOSABLE (Feb 21, 1991)

Other clearances for product code GAD

  • K152538 — JRP Wound Spreader (Apr 13, 2016)
  • K151104 — OTELO LL (Jan 6, 2016)
  • K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (Oct 4, 2013)
  • K071775 — DASH (Aug 7, 2007)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (Apr 26, 2005)
  • K043602 — QUADRANT RETRACTOR SYSTEM (Feb 23, 2005)
  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (Aug 18, 1998)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (Sep 20, 1996)
  • K943875 — VILLALTA RETRACTOR (Nov 9, 1994)

FDA data resources