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510(k) K832709

SKIN STAPLING DEVICE SC2000 by Prosper, Inc. — Product Code GDT

K832709 is an FDA 510(k) premarket notification submitted by Prosper, Inc. for the device "SKIN STAPLING DEVICE SC2000". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. Prosper, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
August 12, 1983
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 Prosper, Inc.

  • K833085 — STAPLE REMOVER SR300P (December 14, 1984)

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)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)
  • K844838 — SKIN STAT II SKIN STAPLING MEDICAL DEVICE (January 23, 1985)

FDA data resources