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510(k) K082116

HEMOSTASYL PASTE by Satelec — Product Code MVL

K082116 is an FDA 510(k) premarket notification submitted by Satelec for the device "HEMOSTASYL PASTE". The FDA issued a decision of Substantially Equivalent on December 17, 2008. The device falls under product code MVL (Cord, Retraction), a Class U device. Satelec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2008
Date Received
July 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Satelec

  • K110379 — AIR-N-GO (December 8, 2011)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K091331 — PIEZOTOME 2 (December 11, 2009)
  • K091252 — IMPLANT CENTER 2 (July 22, 2009)
  • K072181 — MINI LED AUTOFOCUS (September 19, 2007)
  • K071965 — I-SURGE (September 10, 2007)
  • K060275 — PIEZOTOME (May 3, 2006)
  • K060274 — PIEZOTOME (May 1, 2006)
  • K053328 — BIOSPLINT SPLINTING RIBBON (January 25, 2006)
  • K050895 — SURPASSON P5 NEWTRON (April 20, 2005)

Other clearances for product code MVL

  • K254239 — CyClean Cord (March 27, 2026)
  • K253797 — One-Stop (February 27, 2026)
  • K243910 — Retraxil (September 24, 2025)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K213149 — VOCO Retraction Paste (December 9, 2021)
  • K200764 — STATSTIX (October 15, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)

FDA data resources