Product code GCY— General, Plastic Surgery
# 9455 AND #9457 POOLE TIP SUCTION PROBE
- Classification name
- Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device class
- Class 1
- Regulation
- 21 CFR 878.4680
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 96
- First cleared
- Most recent
Market context for product code GCY
FDA has cleared devices under product code GCY between 1976 and 1997, filed by 66 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
last 15 years- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
Top applicants under product code GCY
Adverse events under product code GCY
product code GCY- Malfunction
- 786
- Other
- 1
- Total
- 787
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GCY
- K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM
- K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
- K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
- K960099 — PENROSE DRAIN MODELS 6001 - 6007
- K950754 — MACRO SUCTION TUBE MODEL NO 10061
- K936223 — PRESSURE IRRIGATING SYSTEM
- K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM
- K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
- K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE
- K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES
- K933170 — INMAN POOLE TIP SUCTION PROBE W/TUBING KIT
- K931950 — POOLE TIP SUCTION PROBE
- K931856 — 5.0 MM IRRIGATION/ASPIRATION PROBE
- K925024 — ORC TAPPERED IRRIGATING PROBE
- K923908 — # 9455 AND #9457 POOLE TIP SUCTION PROBE
- K920819 — ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN
- K925989 — KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR
- K925749 — KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML
- K922895 — J-VAC BULB SUCTION RESERVOIR
- K915867 — SOLCOVAC WOUND DRAINAGE SYSTEM
- K915536 — DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
- K910167 — MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
- K905733 — SEROMA-CATH CLOSE DRAINAGE SYSTEM
- K901742 — INAMED SMALL DRAIN SYSTEM
- K901764 — INAMED CONVERTIBLE DRAIN SYSTEM
- K896491 — INAMED CLOSED-WOUND DRAIN SYSTEM
- K896803 — CLOSED WOUND RESERVOIR
- K883982 — DRENOVAC
- K883472 — CLOSED WOUND SUCTION DEVICE
- K883433 — AMBU TWIN PUMP - (MANUAL SUCTION PUMP)
- K881036 — HEMO SUC NUMBER HS100-HS205
- K881012 — WOUND-EVAC RS
- K880650 — HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
- K874645 — CLOSED WOUND DRAINAGE SYSTEMS
- K873332 — MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM
- K863482 — DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
- K863562 — URESIL 150CC BELLOWS RESERVOIR
- K863505 — URESIL CLOSED DRAINAGE RESERVOIR
- K863201 — NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
- K860981 — ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM
- K854424 — BARD PARKER 150CC BELLOWS RESERVOIR
- K853295 — EMODREN EXCHANGEABLE PLASTIC BELLOWS
- K850634 — SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS
- K851084 — ECONOMY 400 CWS WITH PVC DRAINS
- K850011 — PROVAC WOUND HEALING/SUCTION SET
- K850037 — CLOSED WOUND DRAIN
- K844921 — PERIMETER CLOSED WOUND RESEVOIR
- K842710 — CONCEPT C-VAC
- K840913 — PROVAC WOUND DRAINAGE & HEALING SYS
- K833586 — TLS BULB DRAINAGE SYSTEM
- K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT
- K830510 — BBL STREP GROUPING KIT
- K830607 — SUCTION RESERVOIR
- K823284 — STRYKER CONSTAVAC
- K822902 — MINI-VAC DRAIN SYSTEM
- K822032 — LARGE VOLUME CLOSED WOUND SUCTION DRAIN
- K821563 — ARGYLE VAC-U-CARE 100CC SUCTION RESERV
- K820474 — P-S SUCTION RESERVIOR
- K813377 — PS-ROUND SURG. DRAIN & CONNECTOR
- K813341 — WOUND-EVAC
- K811557 — DEPUY HEMODRAIN
- K811203 — SAF SINGLE-USE AEROSOL FILTER
- K810636 — VARIODRAIN
- K810416 — SARNS MINI-SUCKER
- K802973 — ISPVAC TM
- K802214 — COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM
- K801766 — JACKSON-PRATT LARGE VOL. CLOSED WOUND
- K801612 — FRAZIER-FERGUSON SUCTION TUBES (DISP.)
- K801350 — ACUVAC(TM) SUCTION RESERVOIR 400CC AND
- K801442 — P-S SURGICAL DRAIN
- K801443 — P-S SUCTION RESERVOIR
- K801371 — ARGYLE VAC-U-CARE FLAT SILICONE WOUND T.
- K801372 — ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR
- K800543 — SNYDER HYSTERECTOMY Y TUBE KIT
- K800577 — SNYDER HEMOVAC TM VENTED WOUND KIT
- K800578 — SURGIVAC TM
- K800581 — TLS TM SURGICAL DRAINAGE SYSTEM
- K800542 — 100 ML SNYDER HEMOVAC
- K800331 — SURGITEK FOERSTER FACE LIFT DRAIN
- K800081 — DAVOL/ABAMSON SILICONE SUMP DRAIN
- K800014 — DOW CORNING/W RIGHT WOUND DRAINAGE SYS
- K790654 — CLOSED WOUND VACUUM DRAINAGE SYSTEM
- K790763 — MAXI-VAC TM
- K782115 — ASTRA-VAC
- K782028 — ROUND SILICONE DRAIN
- K782026 — FLAT SILICONE DRAIN
- K781400 — HEMOVAC TUBING MATERIAL CHANGE
- K780848 — PORTABLE CLOSED WOUND SUCTION EVACUATOR
- K771015 — VYGON RED-O-PACK
- K760778 — T-TUBE DRAIN, ROUND
- K760700 — SILASTIC BRAND G7-2090A
- K760601 — ARGYLE SUCTION CONTROL KIT
- K760745 — YASARGIL SUCTION TUBE - SMALL
- K760746 — YASARGIL SUCTION TUBE - LARGE
- K760747 — YASARGIL SUCTION TUBE - MEDIUM
- K760257 — SPONGE, RICHARDS WOUND DRAINAGE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.