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510(k) K930316

LUNG RETRACTORS: DAVIDSON, SEMB by Thomasville Medical Assoc. — Product Code GAD

K930316 is an FDA 510(k) premarket notification submitted by Thomasville Medical Assoc. for the device "LUNG RETRACTORS: DAVIDSON, SEMB". The FDA issued a decision of Substantially Equivalent on February 10, 1994. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Thomasville Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
January 22, 1993
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 Thomasville Medical Assoc.

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926532 — ENDO CERVICAL CURETTE (February 25, 1994)
  • K926535 — GOMCO CIRCUMCISION CLAMP (February 25, 1994)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926536 — DISPOSABLE PLASTIC VAGINAL SPECULA (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926471 — MOGAN CIRCUMCISION CLAMP (February 25, 1994)

Other clearances for product code GAD

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

FDA data resources