Panels › Gastroenterology, Urology › Product code GCW · Class 2
Transformer, Endoscope
Regulation 876.1500
0510(k)s in 12 months (1 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in GCW
| Company | 510(k)s | Recalls |
|---|---|---|
| Pentax of America Inc | 0 | 4 |
| EXP Pharmaceutical Services Corp | 0 | 2 |
| Welch Allyn, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2017 | Pentax of America Inc 9200C and 9200D
Laryngeal Strobe
Product Usage:
The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, Terminated |
GCW | None listed |
| Apr 13, 2017 | Pentax of America Inc 9400
Laryngeal Strobe
Product Usage:
The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medica Terminated |
GCW | None listed |
| Apr 13, 2017 | Pentax of America Inc 9310HD
Digital Video Capture Modules
Product Usage:
The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio d Terminated |
GCW | None listed |
| Apr 13, 2017 | Pentax of America Inc 7245C, 7245C/E, 7245D
Computer Digital Video System
Product Usage:
The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior rela Terminated |
GCW | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number TA6035L;
EXP (repackager), Covidien (OEM)
Implantable Terminated |
GCW | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST
Series Technology 80mm - 4.8mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number GIA8048L;
EXP (repackager), Covidien (O Terminated |
GCW | None listed |
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