Product code LWH— General Hospital
PIXEL APP
- Classification name
- Counter, Sponge, Surgical
- Device class
- Class 1
- Regulation
- 21 CFR 880.2740
- Advisory panel
- General Hospital
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code LWH
FDA has cleared devices under product code LWH between 1979 and 2012, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2012
- 2010
- 2009
- 2007
- 2006
- 1998
- 1997
- 1995
- 1991
- 1987
- 1979
Top applicants under product code LWH
Recent clearances under product code LWH
- K121274 — PIXEL APP
- K120473 — PIXEL APP
- K100551 — ORLOCATE SYSTEM MODEL ORL 100
- K093557 — SMARTWAND-DTX
- K073180 — SMARTSPONGE PLUS SYSTEM
- K071355 — SMARTSPONGE SYSTEM
- K061316 — MEDLINE SURGICAL SPONGE SCANNER
- K062642 — RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
- K060076 — SURGICOUNT SAFETY-SPONGE SYSTEM
- K982260 — MARKWELL GAUZE SPONGE
- K972302 — POCKET COUNT OR SAFETCOUNT
- K945144 — SPONGE COUNT
- K912824 — DEVON SPONGE COUNTER BAGS
- K873555 — GORSK SPONGE CONTAINMENT SYSTEM
- K790538 — SPONGE COUNTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.