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510(k) K800435

HEMOSTATIC/TUBE OCCLUDING FORCEPS by Dravon Medical, Inc. — Product Code GEN

K800435 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "HEMOSTATIC/TUBE OCCLUDING FORCEPS". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1980
Date Received
February 27, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Dravon Medical, Inc.

  • K873455 — S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS (September 14, 1987)
  • K860770 — AM-100 I/A AMPAC (April 21, 1986)
  • K832739 — STEDIFLO INFUSION SET (December 22, 1983)
  • K831842 — DRAVON T CLAMP (September 26, 1983)
  • K812771 — PERITONEAL DIALYSIS DRAINAGE (October 19, 1981)
  • K812772 — PERITONEAL DIALYSIS CYCLER SET (8UNIT) (October 19, 1981)
  • K811851 — S-610 SHUNT ADAPTOR SET (August 31, 1981)
  • K782058 — CATHETER, BETA-CAP-PERITONEAL (February 27, 1979)
  • K782057 — CATHETER, RADIOPAQUE TENCKHOFF (February 27, 1979)
  • K781755 — DAP-PAK (February 15, 1979)

Other clearances for product code GEN

  • K031828 — NATURALASE LP ND:YAG LASER (July 17, 2003)
  • K953962 — FORCEPS (September 8, 1995)
  • K932385 — SUTURE REMOVING FORCEPS (August 6, 1993)
  • K904723 — FORCEPS (July 26, 1991)
  • K911159 — PALPATION PROBE (March 29, 1991)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K900948 — GS-1002 GRASPING FORCEP, 5MM WITH RATCHET (April 18, 1990)
  • K900960 — GS-1500 CLAW FORCEP, 10MM (April 18, 1990)
  • K900952 — GS-1200 GRASPING/EXTRACTING FORCEP, 10MM (April 18, 1990)
  • K891896 — TISSUE FORCEPS, VARIOUS TYPES (April 12, 1989)

FDA data resources