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510(k) K913136

LASER ENDOSCOPE DISC DECOMPRESSION KITS by Medical Laser, Inc. — Product Code LRO

K913136 is an FDA 510(k) premarket notification submitted by Medical Laser, Inc. for the device "LASER ENDOSCOPE DISC DECOMPRESSION KITS". The FDA issued a decision of Substantially Equivalent (kit) on November 1, 1991. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Medical Laser, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 1, 1991
Date Received
July 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Surgery Tray
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Other clearances by Medical Laser, Inc.

  • K912265 — MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 (October 10, 1991)
  • K912447 — SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 (September 27, 1991)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K901464 — MEDILASE SERIES 2200 ENDOSCOPE (August 7, 1990)
  • K900894 — MEDILASE SERIES 2100 ENDOSCOPE (June 22, 1990)
  • K900380 — MEDILASE 5010 ENDOSCOPE CONSOLE (May 15, 1990)
  • K895837 — MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR (December 14, 1989)

Other clearances for product code LRO

  • K213481 — Medline General Surgery Tray (May 24, 2022)
  • K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
  • K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL (November 30, 2004)
  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K023276 — AMSINO TRACHEOSTOMY CARE TRAY (December 9, 2002)
  • K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (January 30, 1998)
  • K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
  • K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)
  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)

FDA data resources