Atlas FDA

PGK DEVICE (MODIFIED)

FDA 510(k) clearance K980997 · decided 1998-09-28

Clearance details

K-number
K980997
Device name
PGK DEVICE (MODIFIED)
Applicant
Pgk, Inc.
Decision
Substantially Equivalent
Date received
1998-03-17
Decision date
1998-09-28
Days to decision
195 days
Clearance type
Traditional
Product code
IWJ
Device class
1
Regulation number
892.5650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Vienna, VA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (K010166)Imagyn Medical Technologies, Inc.2001-12-03
REGANES RADIONUCLIDE SEED MAGAZINE (K972554)Avid N.I.T., Inc.1998-02-17
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (K973037)Avid N.I.T., Inc.1998-01-27
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET (K974118)Worldwide Medical Technologies, LLC1998-01-23
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE (K973786)Nw Radiation Therapy Products1998-01-02
N.I.T., INC. NEEDLE GUIDING TEMPLATE (K973638)Avid N.I.T., Inc.1997-12-23
PROSTATE SEEDING NEEDLE (K973184)Promex, Inc.1997-11-21
MANAN PROSTATE UNI-LOCK (K963743)Manan Medical Products, Inc.1996-12-06
WEEKS APPLICATOR (K951052)Duke University Medical Center1996-08-22
MANAN PROSTATE LOCKING INTRODUCER SET (K961377)Manan Medical Products, Inc.1996-07-03
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT (K944522)Medical Device Technologies, Inc.1995-02-24
IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES (K933410)Best Industries1994-12-30

Recalls involving this device

No recalls on record reference this clearance.