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510(k) K810188

AUTO SUTURE GAS POWERED DISP. LDS STAPL by United States Surgical, A Division of Tyco Healthc — Product Code KBC

K810188 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTO SUTURE GAS POWERED DISP. LDS STAPL". The FDA issued a decision of Substantially Equivalent on March 20, 1981. The device falls under product code KBC (Saw, Nasal), a Class I device regulated under 21 CFR 874.4420. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1981
Date Received
January 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saw, Nasal
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by United States Surgical, A Division of Tyco Healthc

  • K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 21, 2007)
  • K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR (September 28, 2007)
  • K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 2, 2006)
  • K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS (October 23, 2006)
  • K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE (September 1, 2006)
  • K061095 — AUTO SUTUR ENDO GIA STAPLERS (May 31, 2006)
  • K050947 — MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE (June 1, 2005)
  • K042412 — MODIFIED SPACEMAKER SYSTEM (September 24, 2004)
  • K040594 — HERCULON SOFT TISSUE REATTACHMENT SYSTEM (March 31, 2004)
  • K032696 — AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& O (December 1, 2003)

Other clearances for product code KBC

  • K811887 — SKIN STAPLE EXTRACTOR (July 27, 1981)
  • K810187 — AUTO SUTURE PSS SKIN STAPLING INSTRUMENT (March 20, 1981)
  • K772379 — JOSEPH SAW (February 2, 1978)

FDA data resources