15 results
10-Q
2024 Q1
GUTS
Fractyl Health Inc.
13 May 24
Quarterly report
4:06pm
incident in which a commercialized medical device product may have caused or contributed to a death or serious injury or in which our product … documented, manufacturers may provide periodic summary reports instead of individual serious incident reports.
Any adverse event involving our
10-K
2023 FY
GUTS
Fractyl Health Inc.
1 Apr 24
Annual report
7:15am
incident associated with the use of a medical device that is made available on the market. A serious incident is any malfunction or deterioration … documented, manufacturers may provide periodic summary reports instead of individual serious incident reports.
Among the new requirements
8-K
EX-3.2
GUTS
Fractyl Health Inc.
6 Feb 24
Amendments to Articles of Incorporation or Bylaws
4:05pm
, the Chief Executive Officer or the President, is authorized to vote, represent and exercise on behalf of this Corporation all rights incident to any
424B4
GUTS
Fractyl Health Inc.
2 Feb 24
Prospectus supplement with pricing info
4:18pm
profits.
Further, under the FDA’s medical device reporting regulations, we are required to report to the FDA any incident in which a commercialized … provide periodic summary reports instead of individual serious incident reports.
Any adverse event involving our products, whether in the United States
S-1/A
GUTS
Fractyl Health Inc.
29 Jan 24
IPO registration (amended)
6:09am
regulations, we are required to report to the FDA any incident in which a commercialized medical device product may have caused or contributed … incident reports.
Any adverse event involving our products, whether in the United States or abroad, could result in future voluntary corrective
S-1/A
EX-3.4
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29 Jan 24
IPO registration (amended)
6:09am
S-1/A
EX-1.1
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29 Jan 24
IPO registration (amended)
6:09am
S-1
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14 Dec 23
IPO registration
3:39pm
S-1
EX-10.1
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14 Dec 23
IPO registration
3:39pm
S-1
EX-3.2
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14 Dec 23
IPO registration
3:39pm
S-1
EX-10.11
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14 Dec 23
IPO registration
3:39pm
S-1
EX-10.15
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14 Dec 23
IPO registration
3:39pm
S-1
EX-10.10
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14 Dec 23
IPO registration
3:39pm
DRS/A
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21 Sep 23
Draft registration statement (amended)
12:00am
DRS/A
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22 Aug 23
Draft registration statement (amended)
12:00am
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