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510(k) K851974

V. MUELLER VITAL SKIN STAPLER by American V. Mueller — Product Code GDT

K851974 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "V. MUELLER VITAL SKIN STAPLER". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1985
Date Received
May 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Removable (Skin)
Device Class
Class I
Regulation Number
878.4760
Review Panel
SU
Submission Type

Other clearances by American V. Mueller

  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K873332 — MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM (September 8, 1987)
  • K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (June 12, 1987)
  • K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (December 29, 1986)
  • K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (August 18, 1986)
  • K861471 — V. MUELLER VITAL CLIP-HEMOSTATIC CLIP (June 6, 1986)
  • K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
  • K854049 — HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (November 27, 1985)
  • K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)
  • K850947 — V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS (April 17, 1985)

Other clearances for product code GDT

  • K963234 — STAPLE REMOVAL KIT (October 21, 1996)
  • K943719 — VISISTAT STAPLER (August 24, 1994)
  • K925526 — MANIPLER DISPOSABLE SKIN STAPLER (June 24, 1993)
  • K915430 — SKIN STAPLE REMOVER KIT (February 28, 1992)
  • K911204 — QUALTEX SKIN STAPLE EXTRACTOR (May 8, 1991)
  • K910586 — AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* (March 7, 1991)
  • K900486 — APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER (April 20, 1990)
  • K861711 — SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE (May 16, 1986)
  • K844838 — SKIN STAT II SKIN STAPLING MEDICAL DEVICE (January 23, 1985)
  • K844837 — VISISTAT SKIN STAPLING DEVICE (January 23, 1985)

FDA data resources