Company ยท US
Valleylab, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2009. Name variants (Inc, Corp, punctuation) are merged.
104510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 69 |
| LFL | Instrument, Ultrasonic Surgical | 9 |
| FRN | Pump, Infusion | 7 |
| FPA | Set, Administration, Intravascular | 4 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 3 |
| GEH | Unit, Cryosurgical, Accessories | 2 |
| HAM | Apparatus, Electrosurgical | 2 |
| LBK | Neurosurgical Ultrasonic Instruments | 2 |
| BWA | Unit, Electrosurgical And Coagulation, With Accessories | 1 |
| DRX | Electrode, Electrocardiograph | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 |
| GFI | Osteotome, Manual | 1 |
| GXY | Electrode, Cutaneous | 1 |
| HGZ | Heater, Perineal, Direct Contact | 1 |
| KGF | Adhesive, Tissue For Aneurysmorrhaphy | 1 |
| NEY | System, Ablation, Microwave And Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2009 | K092879 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER Valleylab | GEI |
| Nov 29, 2006 | K063195 | LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 Valleylab | GEI |
| Apr 27, 2006 | K053535 | VIVAWAVE MICROWAVE ABLATION SYSTEM Valleylab | NEY |
| Mar 15, 2006 | K053290 | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES Valleylab | GEI |
| Feb 3, 2006 | K052796 | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES Valleylab | GEI |
| Aug 11, 2005 | K051644 | VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR Valleylab | GEI |
| Jul 22, 2005 | K051627 | VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT Valleylab | GEI |
| Jan 5, 2005 | K043273 | LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS Valleylab | GEI |
| Nov 12, 2004 | K042216 | COOL-TIP RF ABLATION SYSTEM Valleylab | GEI |
| Sep 28, 2004 | K041587 | LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 Valleylab | GEI |
| May 29, 2003 | K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 Valleylab, Inc. | GEI |
| Apr 2, 2001 | K010010 | VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR Valleylab, Inc. | GEI |
| Mar 26, 2001 | K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 Valleylab, Inc. | GEI |
| Mar 7, 2000 | K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE Valleylab, Inc. | GEI |
| Jan 21, 1999 | K983743 | BISURE LAPAROSCOPIC BIPOLAR FORCEPS Valleylab, Inc. | GEI |
| Aug 28, 1998 | K981916 | LIGASURE VESSEL SEALING SYSTEM Valleylab, Inc. | GEI |
| Jul 6, 1998 | K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM Valleylab, Inc. | LFL |
| Jun 29, 1998 | K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM Valleylab, Inc. | FYD |
| Mar 28, 1997 | K970140 | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH Valleylab, Inc. | GEI |
| Mar 11, 1997 | K964636 | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM Valleylab, Inc. | GEI |
| Jan 16, 1997 | K964601 | CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY Valleylab, Inc. | LFL |
| Jan 9, 1997 | K964602 | DAVIS BAYONET ELECTRODES Valleylab, Inc. | GEI |
| Dec 5, 1996 | K964175 | VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES Valleylab, Inc. | GEI |
| Nov 4, 1996 | K962690 | E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE Valleylab, Inc. | GEI |
| Aug 30, 1996 | K962044 | VALLEYLAB COATED ELECTRODES Valleylab, Inc. | GEI |
| Feb 1, 1996 | K955836 | VALLEYLAB COATED ELECTRODES Valleylab, Inc. | GEI |
| Dec 18, 1995 | K955109 | VL2600 HANDSWITCHING PENCIL WITH HOLSTER Valleylab, Inc. | GEI |
| Nov 20, 1995 | K954229 | ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX Valleylab, Inc. | GEI |
| Aug 23, 1995 | K953737 | VL7600 REM PATIENT RETURN ELECTRODE Valleylab, Inc. | GEI |
| Aug 21, 1995 | K953195 | VALLEYLAB FORCE 300 Valleylab, Inc. | GEI |
| Jul 11, 1995 | K934628 | CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS Valleylab, Inc. | LFL |
| Jun 13, 1995 | K945688 | VALLEYLAB PROCISION(TM) SYSTEM Valleylab, Inc. | GEI |
| Jun 6, 1995 | K946177 | VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM Valleylab, Inc. | GEI |
| Jun 5, 1995 | K944602 | VALLEYLAB FORCE FX Valleylab, Inc. | GEI |
| Apr 10, 1995 | K950945 | COOPER LASER SONICS CUSA MODEL 200 Valleylab, Inc. | LFL |
| Feb 10, 1995 | K950188 | VALLEYLAB COATED ELECTRODES Valleylab, Inc. | GEI |
| Nov 30, 1994 | K944244 | MODEL E278OR-ASP SERIES RETRACTABLE Valleylab, Inc. | GEI |
| Nov 9, 1994 | K945260 | E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS Valleylab, Inc. | GEI |
| Sep 23, 1994 | K943865 | FORCE GSU-SLPM SYSTEM Valleylab, Inc. | GEI |
| Sep 21, 1994 | K942579 | FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22 Valleylab, Inc. | GEI |
| Sep 16, 1994 | K931902 | CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS. Valleylab, Inc. | LFL |
| May 17, 1994 | K942183 | E2550 REUSABLE HANDSWITCHING PENCIL Valleylab, Inc. | GEI |
| May 10, 1994 | K941968 | VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC Valleylab, Inc. | GEI |
| Mar 25, 1994 | K921885 | E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES Valleylab, Inc. | HGZ |
| Feb 12, 1994 | K926481 | VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET Valleylab, Inc. | GEI |
| Nov 2, 1993 | K933181 | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 Valleylab, Inc. | GFI |
| Oct 12, 1993 | K933239 | CV720-727-000, MICROTIP AND FLUE PAK Valleylab, Inc. | LFL |
| Sep 29, 1993 | K925647 | VALLEYLAB #E2751 & E2780R LAPAROSCOPIC HANDPIECE Valleylab, Inc. | GEI |
| Sep 7, 1993 | K922206 | SURGISTAT Valleylab, Inc. | HGI |
| Jul 27, 1993 | K931028 | VALLEYLAB RETRACTABLE ELECTRODES Valleylab, Inc. | GEI |
Newest 50 of 104.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2003 | Valleylab, Inc Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads. Terminated |
HAM | K000079 |
| Aug 12, 2003 | Valleylab, Inc Radionics Disposable Grounding Plate Terminated |
HAM | K000079 |