Rusch, Inc.
Jeffrey, NH, US
Rusch, Inc. appears in FDA device records in Jeffrey, NH. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Rusch, Inc. between 1993 and 1998. The busiest year on record is 1993, with 10. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 10 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980870 | RUSCH SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | |
| K970021 | RUSCH SUPRAPUBIC TRAY | KOB | Substantially Equivalent | |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | FCM | Substantially Equivalent | |
| K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE | JOH | Substantially Equivalent | |
| K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | BTR | Substantially Equivalent | |
| K953963 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | BTS | Substantially Equivalent | |
| K922567 | LOW PROFILE CATHETER | KNT | Unknown | |
| K953593 | RUSCH TRACHEAL BRONCHIAL Y STENT | NYT | Substantially Equivalent - Subject to Tracking Reg. | |
| K952100 | RUSCH ENDOTRACHEAL TUBE STYLET | BSR | Substantially Equivalent | |
| K952187 | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE | KOB | Substantially Equivalent | |
| K922998 | ENFUSE ENTERAL FEEDING TUBE | KNT | Substantially Equivalent | |
| K925508 | RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP | BTR | Substantially Equivalent | |
| K925507 | RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP | BTR | Substantially Equivalent | |
| K925505 | RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE | BTR | Substantially Equivalent | |
| K925506 | RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE | BTR | Substantially Equivalent | |
| K931164 | RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY | BTR | Substantially Equivalent | |
| K931163 | RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE | BTR | Substantially Equivalent | |
| K931166 | RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY | BTR | Substantially Equivalent | |
| K931165 | RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE | BTR | Substantially Equivalent | |
| K923003 | PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN. | BSP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EZLCatheter, Retention Type, Balloon
- KOBCatheter, Suprapubic (And Accessories)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- NYTProsthesis, Tracheal, Expandable, Polymeric
- BSRStylet, Tracheal Tube
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- JOHTube Tracheostomy And Tube Cuff
- BTSTube, Bronchial (W/Wo Connector)
- BTRTube, Tracheal (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain