Panels › General Hospital › Product code LWH · Class 1
Counter, Sponge, Surgical
Regulation 880.2740
0510(k)s in 12 months (15 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in LWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Clearcount Medical Solutions | 3 | 0 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 3 |
| Devon Industries, Inc. | 2 | 0 |
| Gauss Surgical, Inc., | 2 | 0 |
| Gorsk, Inc. | 1 | 0 |
| Haldor Advanced Technologies, Ltd. | 1 | 0 |
| Markwell Intl., Inc. | 1 | 0 |
| Medline Industries, Inc. | 1 | 0 |
| Michael Fischer Assoc. | 1 | 0 |
| Rf Surgical Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | United Orthopedic Corp. Brand Name: U2 Total Knee System
Product Name: Femoral offset bushing, 0mm and 4mm
Model/Catalog Number: 9323-5310
Software Version: N/A
Product Description: Manual Orthopedic Surgical Instrument
Comp Open, Classified |
LWH | None listed |
| Jun 15, 2022 | Stryker Instruments Div. of Stryker Corporation SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during su Terminated |
LWH | K060076 |
| Apr 13, 2016 | Stryker Instruments Div. of Stryker Corporation SurgiCounter scanner, part of the SurgiCount Safety-Sponge System.
Model numbers 0694-097-000 and 0694-097-001.
Product Usage:
The SurgiCount Safety Sponge System is indicated for use in counting Terminated |
LWH | K060076 |
| Jan 15, 2015 | Stryker Instruments Div. of Stryker Corporation The SurgiCounter Charging Cradle
Product Usage:
SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safet Terminated |
LWH | K060076 |
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