Gesco Intl., Inc.
Walker, MI, US
Gesco Intl., Inc. appears in FDA device records in Walker, MI. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Gesco Intl., Inc. between 1978 and 1995. The busiest year on record is 1994, with 6. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1983 | 1 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1990 | 2 |
| 1991 | 5 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 6 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | LJS | Substantially Equivalent | |
| K940953 | UMBILI-CATH-S | FOS | Substantially Equivalent | |
| K940870 | UMBILI-CATH | FOS | Substantially Equivalent | |
| K940952 | UMBILI-CATH-S-DL | FOS | Substantially Equivalent | |
| K941672 | URI-CATH CATHETER | GBM | Substantially Equivalent | |
| K941232 | THORA-CATH | JOL | Substantially Equivalent | |
| K940871 | UMBILI-CATH-P | FOS | Substantially Equivalent | |
| K931989 | VENTRI-CATH | JXG | Substantially Equivalent | |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | MCY | Unknown | |
| K923591 | PALA-NATE | BTR | Substantially Equivalent | |
| K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER | DYB | Substantially Equivalent | |
| K911326 | OBSTETRICAL VACUUM CUP | HDB | Substantially Equivalent | |
| K910652 | SPINAL TAP NEEDLE | BSP | Substantially Equivalent | |
| K911607 | GESCO UMBILI-CATH | FOS | Substantially Equivalent | |
| K911215 | GESCO PER-Q-CATH NEEDLE | LIT | Substantially Equivalent | |
| K910622 | GESCO PER-Q-CATH REPAIR KIT | LJS | Unknown | |
| K895942 | GESCO DUAL LUMEN PER-Q-CATH-DL | FOZ | Substantially Equivalent | |
| K896041 | GESCO DUAL LUMEN UMBILICATH II-DL | FOS | Unknown | |
| K882647 | GESCO CATHETERIZATION TRAY | GBQ | Unknown | |
| K872221 | DIALY-NATE SET & DIALY-NATE CATHETER | FKO | Substantially Equivalent | |
| K870962 | GESCO ASPIRATOR | BSY | Substantially Equivalent | |
| K861090 | NUTRI-CATH - FEEDING TUBE | KNT | Substantially Equivalent | |
| K852490 | URI-CATH SYSTEM | KNX | Substantially Equivalent | |
| K851385 | THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE | JOL | Substantially Equivalent | |
| K831845 | PER-Q-CATH TRAY | LJS | Substantially Equivalent | |
| K772288 | CATHETER, CHOLANGIOGRAM, OPERATIVE | GBZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JOLCatheter And Tip, Suction
- LITCatheter, Angioplasty, Peripheral, Transluminal
- GBZCatheter, Cholangiography
- GBQCatheter, Continuous Irrigation
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FKOCatheter, Peritoneal Dialysis, Single Use
- FOSCatheter, Umbilical Artery
- GBMCatheter, Urethral
- BSYCatheters, Suction, Tracheobronchial
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- HDBExtractor, Vacuum, Fetal
- DYBIntroducer, Catheter
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- JXGShunt, Central Nervous System And Components
- BTRTube, Tracheal (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- MCYWound Dressing Kit
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain